Specialist I, Quality Assurance

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Job Description

The Quality Assurance Specialist I will support business operations at the Columbia, MD site by supporting and assuring the efficacy of established site quality management systems including CAPA, NCMR, Change Control, Deviation, and Quality Metrics processes. The QA Specialist I plays a key role in the execution of the organization’s Quality System and assists in continuous improvement of the Quality System.

Responsibilities

• Coordinate and participate in the Quality Systems processes related to Change Control, CAPA, Nonconformances, MRB, Deviations and Quality Metrics.
• Responsibilities include but are not limited to:
• Acting in the capacity of Change Analyst for ECR process in Agile. Coordinate and conduct Change Review Board meetings.
• Conducting CAPA Board Review Board Meetings and creating meeting minutes. Is a process owner for Digital TrackWise for CAPA.
• Assisting and interacting with NCMR, MRB, Deviation Owners and ensuring that these Quality Records are processed in a timely manner. Is a process owner for MasterControl for NC/ MRB modules.
• Trend Quality System – Publish Weekly and Monthly Quality Metrics and coordinates Data Review Board meetings. Support data trending for Quarterly Management Review data trending and metrics.
• Participate and coordinate activities for internal and external audits. Conduct Internal audits.
• Maintain and revise site Quality System procedures for Change Control, CAPA, NCMR, CAPA, Deviations and related site audit procedures for internal and external audits.
• Facilitate Good Documentation Practices
• Participate in review meetings with Quality team on site SOP creation and revision
• Other duties as assigned by supervisor
  
  

Required Skills & Knowledge

• Education/ Experience:: Bachelor’s degree or equivalent with 0 - 2 year of experience; or Associate degree, or equivalent with a minimum of 3 years of experience; orHigh School degree or equivalent with a minimum of 5 years of experience
• Understanding of 21 CFR 820, ISO 13485, and ISO 14971 preferred.
• Self-motivator with an analytic nature. Strong organizational, communication, and interpersonal skills.
• Well informed and proficient in the use of modern technology, especially electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications. Experience in Agile and Oracle systems is a plus.
• Ability to obtain Quality training and/or certifications as needed.
• Organized, attention to detail and excellent analytical skills.
• Excellent communication skills, both written and verbal.
• Excellent organization, prioritization and problem-solving skills
• Able to lift 40 lbs.
  
  

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This Site Is Governed Solely By Applicable U.S. Laws And Governmental Regulations. If You'd Like More Information On Your Rights Under The Law, Please See The Following Notices

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected] or call us at 855-936-2666.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)